Drugs in the Pipeline
Poziotinib Under Review for Previously Treated HER2 Exon 20 Insertion Mutation Positive NSCLC
A PDUFA target date of November 24, 2022 has been set for the application.
Your search for non small cell lung cancer returned 110 results
Drugs in the Pipeline
Adagrasib Under Review for Previously Treated KRAS G12C-Mutated NSCLC
The application is supported by data from the registration-enabling cohort of the phase 2 KRYSTAL-1 study evaluating adagrasib in adults with NSCLC harboring the KRASG12C mutation following prior systemic therapy.
Drugs in the Pipeline
Trastuzumab Deruxtecan Gets Priority Review for Previously Treated HER2-Mutant Metastatic NSCLC
The sBLA is supported by data from the phase 2 DESTINY-Lung01 trial, along with a phase 1 trial published in Cancer Discovery.
Drugs in the Pipeline
FDA Grants Xalkori Priority Review for Non-Small Cell Lung Cancer
The FDA has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for Xalkori (crizotinib; Pfizer).
Drugs in the Pipeline
Study: Longer Overall Survival for Keytruda vs. Docetaxel
Merck announced that the KEYNOTE-010 study of Keytruda (pembrolizumab) in advanced non-small-cell lung cancer (NSCLC) met its primary endpoint.
Drugs in the Pipeline
PARP Inhibitor Veliparib Gets Orphan Drug Status from FDA
AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to veliparib, an investigational combination with chemotherapies or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).
Drugs in the Pipeline
Atezolizumab Gets Priority Review as Adjuvant Treatment for Early NSCLC
The sBLA is supported by data from the IMpower010 study that compared atezolizumab with best supportive care in 1005 adults with Stage IB-IIIA NSCLC after resection and adjuvant chemotherapy.
Drugs in the Pipeline
Positive Outcomes Observed with Xalkori in NSCLC Study
Pfizer announced results from PROFILE 1014, a Phase 3 study of Xalkori (crizotinib) in previously untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-squamous non-small cell lung cancer (NSCLC).
Drugs in the Pipeline
Patritumab Deruxtecan Gets Breakthrough Tx Status for Metastatic EGFR-Mutated NSCLC
Patritumab deruxtecan consists of a fully human anti-HER3 IgG1 monoclonal antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via a stable tetrapeptide-based cleavable linker.
Drugs in the Pipeline
AbbVie Launches Veliparib Trial for NSCLC
AbbVie announced the initiation of a Phase 3 trial evaluating the safety and efficacy of veliparib (ABT-888) in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).
